A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)

July 28, 2021 updated by: AbbVie (prior sponsor, Abbott)

A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Coadministration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection (PEARL-I)

The purpose of this study is to evaluate the safety and efficacy of co-administration of ABT-450 (also known as paritaprevir) with ritonavir (ABT-450/r) and ABT-267 (also known as ombitasvir) in adults with chronic hepatitis C virus infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a Phase 2, randomized, open-label, combination treatment study of the 2-DAA regimen (ABT-450 150 mg QD + ritonavir 100 mg QD + ABT-267 25 mg QD) in adult HCV GT1b-infected treatment-naïve and Pegylated-interferon/ribavirin (pegIFN/RBV) treatment-experienced participants without cirrhosis and with compensated cirrhosis, and in adult GT4-infected treatment-naïve and pegIFN/RBV treatment-experienced participants without cirrhosis. Treatment Group 5 was not open to enrollment, based on a protocol-specified interim review of results from the treatment-naïve GT4 Groups 1 and 4 that indicated higher sustained virologic response (SVR) rates among participants receiving the 2-DAA regimen with RBV. All other groups completed the study.

Study Type

Interventional

Enrollment (Actual)

316

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Females must be practicing specific forms of birth control on study treatment, or be postmenopausal for more than 2 years or surgically sterile

  • Subjects must meet one of the following:

    • Treatment-naive: Subject has never received antiviral treatment for hepatitis C infection OR
    • Treatment Experienced (Prior null responders, Partial responders or Relapsers to pegIFN/RBV);
  • Body mass index (BMI) is ≥ 18 to < 38 kg/m^2.
  • Chronic HCV genotype 1b infection/with or without cirrhosis or HCV genotype 4 infection/without cirrhosis for at least 6 months prior to study screening.
  • Subject has plasma HCV RNA level > 10,000 IU/mL at Screening

Exclusion Criteria:

  • History of severe, life-threatening or other significant sensitivity to any drug.
  • Females who were pregnant or planned to become pregnant, or breastfeeding, or GT4-infected males whose partners were pregnant or planning to become pregnant within 7 months (or per local RBV label) after their last dose of study drug/RBV.
  • Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
  • Positive test result for hepatitis B surface antigen or anti-Human Immunodeficiency Virus (HIV) antibodies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
Drug: ABT-450/r
Tablet; ABT-450; Capsule; ritonavir
Other Names:
  • ABT-450 also known as paritaprevir
Drug: ABT-267
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
EXPERIMENTAL: Group 2
ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
Drug: ABT-450/r
Tablet; ABT-450; Capsule; ritonavir
Other Names:
  • ABT-450 also known as paritaprevir
Drug: ABT-267
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
EXPERIMENTAL: Group 3
ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
Drug: ABT-450/r
Tablet; ABT-450; Capsule; ritonavir
Other Names:
  • ABT-450 also known as paritaprevir
Drug: ABT-267
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
EXPERIMENTAL: Group 4
ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
Drug: Ribavirin (RBV)
Tablet
Drug: ABT-450/r
Tablet; ABT-450; Capsule; ritonavir
Other Names:
  • ABT-450 also known as paritaprevir
Drug: ABT-267
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
EXPERIMENTAL: Group 5
ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-experienced, HCV GT4-infected participants
Drug: ABT-450/r
Tablet; ABT-450; Capsule; ritonavir
Other Names:
  • ABT-450 also known as paritaprevir
Drug: ABT-267
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
EXPERIMENTAL: Group 6
ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
Drug: Ribavirin (RBV)
Tablet
Drug: ABT-450/r
Tablet; ABT-450; Capsule; ritonavir
Other Names:
  • ABT-450 also known as paritaprevir
Drug: ABT-267
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
EXPERIMENTAL: Group 7
ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
Drug: ABT-450/r
Tablet; ABT-450; Capsule; ritonavir
Other Names:
  • ABT-450 also known as paritaprevir
Drug: ABT-267
Tablet
Other Names:
  • ABT-267 also known as ombitasvir
EXPERIMENTAL: Group 8
ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
Drug: ABT-450/r
Tablet; ABT-450; Capsule; ritonavir
Other Names:
  • ABT-450 also known as paritaprevir
Drug: ABT-267
Tablet
Other Names:
  • ABT-267 also known as ombitasvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants in Each Treatment Group With Sustained Virologic Response 12 Weeks Post-treatment
Time Frame: 12 weeks after the last actual dose of study drug
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 12 weeks after the last dose of study drug.
12 weeks after the last actual dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants in Each Treatment Group With Sustained Virologic Response 24 Weeks Post-treatment
Time Frame: 24 weeks after the last actual dose of study drug
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [<LLOQ]) 24 weeks after the last dose of study drug.
24 weeks after the last actual dose of study drug
Percentage of Participants in Each Treatment Group With On-treatment Virologic Failure.
Time Frame: Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8
Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
Baseline (Day 1), Day 3, and Treatment Weeks 1, 2 ,3 ,4, 6, 8, 10, and 12 for all participants and Treatment Weeks 16, 20 and 24 for Groups 7 and 8
Percentage of Participants in Each Treatment Group With Post-treatment Virologic Relapse.
Time Frame: Within 12 weeks after the last dose of study drug
Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.
Within 12 weeks after the last dose of study drug
Percentage of Participants in Each Treatment Group With Treatment-emergent Adverse Events
Time Frame: From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.
Treatment-emergent adverse events were defined as any event that began or worsened in severity after initiation of study drug through 30 days after the last dose of study drug.
From the start of study drug administration until 30 days after the last dose,16 weeks for Groups 1, 2, 3, 4, and 6, and 28 weeks for Groups 7 and 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Nilou Mobashery, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

September 12, 2012

First Submitted That Met QC Criteria

September 12, 2012

First Posted (ESTIMATE)

September 14, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-393
  • 2011-005762-38 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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